Celcuity (CELC) investor relations material

Lead asset and clinical programs

• Gedatolisib is a pan-PI3K/mTOR inhibitor with three phase III programs in HR-positive, HER2-negative breast cancer, including both second-line and first-line settings, and a phase 1b/2 study in metastatic castration-resistant prostate cancer showing promising data.

• The Victoria I trial targets post-CDK4/6 patients, while Victoria II focuses on treatment-naive, endocrine therapy-resistant women, representing about a third of metastatic breast cancer cases.

• Eligibility criteria for Victoria I allow inclusion of patients who received CDK4/6 in the adjuvant setting, potentially opening the drug to first-line use.

• The primary endpoint for the mutant cohort in Victoria I is PFS, with data expected end of Q1 or Q2 2026; no interim analysis is planned.

• The triplet arm (Geta + fulvestrant + CDK4/6) in Victoria I showed a hazard ratio of 0.24, the lowest reported in breast cancer, indicating strong efficacy.

Mechanism of action and differentiation

• Gedatolisib comprehensively inhibits all four PI3K isoforms and both mTOR complexes, overcoming adaptive resistance seen with single-target inhibitors.

• The drug is 300x more potent than approved alpha inhibitors and is cytotoxic, not just cytostatic, leading to anti-tumor effects even in wild-type patients.

• Dosing is three times per 28-day cycle, resulting in lower toxicity and a better safety profile compared to other drugs in this pathway.

• Hyperglycemia rates are significantly lower (10% all-grade, 2% grade 3) than with other PI3K inhibitors, with no discontinuations or dose reductions.

Market potential and commercial strategy

• The second-line HR-positive, HER2-negative breast cancer market is about 37,000 patients, with 40% mutant and 60% wild-type, representing a $6 billion market opportunity.

• Commercial launch preparations began in Q1 2024, with most of the team in place except for the sales force, which will be built closer to approval.

• Typical sales teams in this space have 80–90 representatives; pricing benchmarks are set by current PI3K inhibitors at $25,000 per cycle.